Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

NCT00016055 | Unknown Phase 1

• 3 other identifiers: CDR0000068590STLMC-IMM-0002NCI-V01-1657
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose at completion of study

• Safety as measured by NCI common toxicity table at completion of study

Interventions

lymphokine-activated killer cells BIOLOGICAL

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic melanoma * No ocular or mucosal melanoma * Must meet one of the following criteria: * Failed standard or salvage therapy * Ineligible for standard therapy due to concurrent illness * Declined standard therapy * Received at least 1 prior therapy for metastatic disease * Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases * No leptomeningeal metastases * At least 1 documented site of bidimensionally measurable disease by MRI or CT scan * Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * No coagulation disorder such as thrombophlebitis Hepatic: * Bilirubin less than 2.0 mg/dL * AST and ALT less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN Renal: * Creatinine less than 1.5 times ULN * BUN less than 1.5 times ULN Cardiovascular: * Ejection fraction at least 45% * No active ischemia * No unstable angina * No uncontrolled congestive heart failure Pulmonary: * Normal pulmonary function tests within the past month * FEV1 or FVC more than 65% predicted * No uncontrolled pulmonary embolism Gastrointestinal: * No frequent vomiting * No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) Other: * No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks * No uncontrolled cortical dysfunction * No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality) * No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix * No significant psychiatric disease that would preclude study compliance * No AIDS-related illness * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * More than 1 month since prior biologic therapy or immunotherapy Chemotherapy: * More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: * At least 4 weeks since prior steroid therapy or steroid-containing compounds * At least 2 weeks since prior topical or inhaled steroids Radiotherapy: * See Disease Characteristics * More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: * At least 1 week since prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Luke's Medical Center: lead

Study Sites (1)

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John P. Hanson, MD

  St. Luke's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2000
• Last Updated: September 20, 2013

Record last verified: 2006-11

Locations

US (1)